Andrews Surgical Innovations, Ltd.

Andrews Surgical Innovations, Ltd. specializes in surgical devices for minimally invasive procedures. Their primary product is the Andrews Introducer (Model ASI01), which is designed to assist in such interventions. The company’s portfolio is focused on Class I devices, meaning these products are generally considered low-risk and subject to less stringent regulatory oversight compared to higher-risk categories.

The company is headquartered in the United States. This location influences its regulatory framework, as its devices are subject to U.S. Food and Drug Administration (FDA) requirements, including the 510(k) pathway for device authorization.

The Andrews Introducer (Model ASI01) is listed in the FDA’s 510(k) registry. This pathway is used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulatory standards before commercialization.

Andrews Surgical Innovations, Ltd.’s devices fall under FDA Class I classification. This classification is assigned based on risk assessment criteria—Class I devices are typically low-risk and pose minimal harm to patients if they malfunction. As a result, they require less regulatory scrutiny, though compliance with manufacturing and labeling standards is still mandatory.